E-cigarette or drug delivery device?

July 20, 2011

Devices marketed as "electronic cigarettes" are in reality crude drug delivery systems for refined nicotine, posing unknown risks with little new benefits to smokers, according to tobacco control experts.

In a "Perspective" published today in the New England Journal of Medicine, researchers from the Legacy's Steven A. Schroeder National Institute for Tobacco Research and Policy Studies explore the current regulatory climate around electronic cigarettes ("e-cigarettes") and their safety. The authors, Nathan K. Cobb, MD, a pulmonologist and assistant professor at Georgetown University Medical Center, and David B. Abrams, PhD, executive director of the Schroeder Institute, also question future implications for physicians, policy makers and e-cigarette users.

E-cigarettes are constructed to mimic real cigarettes in size and appearance, but contain no tobacco and are not cigarettes at all. In reality they are delivery devices for refined nicotine, having more in common with inhalers used to treat asthma or other delivery devices for both approved and illicit drugs. Though individual brands vary in construction, the products generally produce a propylene glycol mist containing nicotine along with flavorings and other chemicals.

Currently, three interrelated products are being sold: the delivery device itself; cartridges that can contain up to 20 mg of nicotine; and refill kits that allow consumers to fill used cartridges with replacement nicotine solution. Some refill bottles, easily obtained over the Internet, contain enough nicotine to kill an adult if accidentally ingested.

The U.S. Food and Drug Administration (FDA) announced April 25, 2011, that it would regulate e-cigarettes as "tobacco products" and not as "drug-delivery devices." That action came after federal courts blocked the agency from regulating the products as drug-delivery devices. The courts maintained that, under the 2009 Family Smoking Prevention and Tobacco Control Act (FSPTCA), the FDA must regulate as tobacco products any product that contains nicotine from tobacco and that makes no claims to be therapeutic. These decisions together, the authors note, "upend[ed] the status quo" by having the effect of allowing the sale of unregulated refined nicotine directly to consumers, unless and until the FDA takes further action.

"The court's decision that e-cigarettes should be regulated as tobacco products and not as drug-delivery devices has substantially delayed the FDA regulatory process that normally protects the public health. It has the practical effect of allowing manufacturers to sell potentially dangerous refined nicotine products directly to consumers," said Cobb. "It is entirely possible that future modifications to the products will improve the efficiency of nicotine delivery and could dramatically increase the risks of addiction, abuse and serious overdose."

While most devices and nicotine fluids are produced by small manufacturers, Cobb and Abrams note that the fact that leading cigarette manufacturers Philip Morris International and British American Tobacco recently purchased sophisticated nicotine inhaler technologies may be an indication that both companies are developing next generation nicotine delivery devices of their own.

Abrams, a professor at Johns Hopkins Bloomberg School of Public Health added "Any refined nicotine product, whether used for smoking cessation and tested and approved by the FDA (like the Nicotrol inhaler) or a new product designed for 'reduced or modified' risk, can and must be tested and strictly regulated before being introduced to the market".

The authors argue that a comprehensive approach to regulating products containing refined nicotine is needed to protect the public's health and should involve Congress, the courts and the FDA.

The devices do not reliably deliver nicotine, and have not been sufficiently evaluated in scientific studies the way the FDA requires of other drugs and devices used for smoking cessation. Smokers attempting to use e-cigarettes as quitting aids will most likely find them ineffective due to the fluctuating nicotine content and unpredictable delivery.

Manufacturers sell cartridges with a range of up to 20 milligrams of nicotine. However, refill kits allow consumers to fill used cartridges with replacement solutions at much higher doses. In fact, the devices are not limited to delivering nicotine. The paper notes that instructions for filling cartridges with marijuana hash oil can be easily accessed on the Internet.

The safety of inhaling propylene glycol over an extended period of time has not been studied in humans.

E-cigarettes may serve as a "bridge product" that smokers use in places where traditional tobacco smoking is prohibited, thus perpetuating their addiction and use of real cigarettes. Additionally, they may be used as a 'starter' product for young people considering smoking, especially since the cartridges can be purchased over the Internet with tempting flavoring like grape and chocolate.

In their conclusion, Cobb and Abrams counter the argument made by e-cigarette advocates that taking the devices off the market could mean current users would be forced to return to traditional tobacco products. Instead, the two researchers point to the multiple pharmaceutical-grade nicotine products on the market that have been regulated, approved and deemed safe and effective by the FDA, including patches, gums, lozenges, nasal sprays and even an FDA-approved inhaler. The two researchers also state that current users should pursue research-proven effective cessation tools, such as nicotine replacement products, telephone quit lines, and Web-based cessation services, as well as non-nicotine pharmacotherapies like bupropion and varenicline.

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15 comments

Of course, Cobb and Abrams would not want nicotine users to be able to use a device which delivers nicotine without the hundreds of chemicals which cigarettes contain. Besides, people can use these products inside which defeats the purpose of punishment for smoking.

I have to agree with dogbert. The qualms Cobb and Abrams brought up are from user incompetence.

1 - There are e-cigarettes that don't allow refilling by combining the cartridge and atomizer. Completely negating the possibility of over filling.

2 - Saying that the device can be used to smoke Marijuana hash oil is like saying that a heated spoon and a tube can be used to smoke marijuana hash oil. It's not the most complicated process in the world. Should we blame cigarettes for being tube shaped and allowing people to put ground marijuana into them? Etc.

Are we saying that regulation is GOOD for tabacco producers? Which government official is on the take with the tabacco farmers trying to prevent this safer product from getting wide spread acceptance from the smoking public.

But I hate punishing smokers for smoking a whole lot more. And on this particular topic, the thing I hate the most is when various governments/governmental agencies dictate to private property owners whether they can or cannot allow smoking on their own property.

I'd rather sit in a smoke filled restaurant all day every day than have a restaurant be forced to not allow smoking.

You'll notice I'm not getting my way. Pity that.

The court's decision that e-cigarettes should be regulated as tobacco products and not as drug-delivery devices has substantially delayed the FDA regulatory process that normally protects the public health.

In other words, as bad as it is - it could be worse. And eventually probably will be.

@FrankHerbert: 5 stars for agreeing with the general sentiment (to my utmost astonishment, I must add, there's hope for you yet!), but 1 star for downranking dogbert and freethinking on such a flimsy basis. While I don't subscribe to any "conspiracy" on the matter, they're certainly free to speculate on such, given their valid concerns. Concerns, I might add, with which you've voiced general agreement.

I'll phrase this as a question rather than an accusation: Might you be letting your well-worn adversarial position with these two temper your judgement?

Might you be letting your well-worn adversarial position with these two temper your judgement?

Certainly! I have nothing but contempt for them. However, you seem to share much more in common ideologically with them than me, but I have little problem with you.

It's all in how your present your ideas I guess. I believe I gave up on Marjon very early on after trying to find some common ground with him and being told "I don't believe you." He did this in a topic just today to SteveL, if I recall correctly.

... you seem to share much more in common ideologically with them than me, but I have little problem with you.

Well thank you! I enjoy our sparring.

Yes, I am a far right-wing, arch-conservative, AGW denying, "left-ophobe", but I usually try to be a nice guy. It's because I come from a pathologically polite family, but given all the pathologies out there - if I had to choose one - that's the one I'd go with so I guess I got lucky.

Or, of course, to round it out, I should say "God smiled on me!"

If you'll kindly do me just one favor, the one I'd sincerely ask is this: If for some reason or another you get in the mood to write me off one day, before you do so would you please first just call me a jerk "to my face" as it were? All my friends have permission to do this without repercussions (seriously), and it can be a very helpful clue to me sometimes. I'm very hard to offend.

I've smoked both cigarettes and electronic cigs for a while, now I have quit both.

It seems to me that everyone has been saying for YEARS that we don't know the effects of these new e-cigs, well genius's there is only one way to find out! How long does it take to do a study of propylene glycol toxicity? I mean seriously whats taking so long to find out? And for the record we are comparing it to smoking cigs not sitting in an easy chair with a glass of green tea, how much worse could it be than smoking something which causes gene mutation in minutes due to all the carcinogens and benzene/benzene compounds?

As for you conspiracy nuts, why would there be a fight over elec vs classic cigs? Whatever chems they put in cigs could just as easily be added to your e-cig juice. Unless! the fight is just a cover to secretly distract you while aliens infiltrate you dogs brains and use them to force you to get exercise from walking your dogs.....it all makes sense now.

In suggesting that e-cigarette users cease, desist and take up FDA-approved smoking cessation devices, Cobb and Abrams expose their fundamental misunderstanding of a small but crucial detail: most users DON'T WANT TO QUIT SMOKING. They want a reduced-risk ALTERNATIVE to smoking.

They do not want to chew gum, nor wear a patch on their arm-- nor use any product of that sort--for much the same reason as a dieter would prefer not to be fed intravenously, taking in controlled doses of calories, but never tasting, chewing or swallowing.

And absent e-cigarettes, ex-smoking vapers would return to cigarettes in a New York minute--Cobb's and Abrams' conjecture from the clouds of academia notwithstanding.

Incidentally, regarding the gums and patches: the FDA's own testing of them revealed the trace presence of carcinogens, at essentially the same levels as found in e-cigarette liquids.

Let's see now, Dr. Cobb is a paid consultant to Healthways Inc, the current owner of the QuitNet system. They make their profits based on an internet smoking cessation site which heavily promotes smoking cessation drugs.

Then we have Dr. Abrams, who has received grant funding from multiple pharmaceutical companies that have investigated or manufactured smoking cessation drugs, including Eli Lilly, Merck, Glaxo-Wellcome, SmithKline Beecham, Bristol-Myers Squibb, and Pfizer to name a few. He's also served as a senior scientific advisor for Johnson & Johnson who sells a number of NRT products.

Did they divulge these conflicts and do they have anything to gain by seeing popular non-pharma, much safer than smoking products like E Cigs and Swedish snus? You betcha, but anything is fair for these people if it keeps their profits coming in.

If you see my previous comment I stated "Which government official is on the take with the tabacco farmers trying to prevent this safer product from getting wide spread acceptance from the smoking public."

Sorry for blaming tabacco farmers, I didn't think about anti-smoking products. Another example of how progressives use regulations to support friends even if those regulations hurt people.

Cobb and Abrams claim that smokers attempting to use e-cigarettes for smoking cessation will most likely find them ineffective. This is contradicted by the evidence. In numerous population surveys of e-cigarette users, between 31 and 80% have stopped inhaling smoke. Compare that to the success rates of nicotine replacement products at best, 7%.

They claim that taking the devices off the market would not force current users to return to traditional tobacco products. A recently published article in the journal Addiction reported that 77% of 2,962 e-cigarette consumers are using them to prevent relapsing to smoking.

E-cigarette users have already tried repeatedly to stop smoking with the products Cobb and Abrams are pushing, and 86% found those products ineffective. So Cobb and Abrams are suggesting that e-cigarette consumers stop using the one thing that finally worked and switch back to using the products that never worked. Sorry guys, that sounds like a dumb idea to me.

I don't give a damn what you call it. I smoked tobacco cigarettes for more than 52 years. Since I found out about, and started using, the so called eCigarette. . .I haven't smoked any tobacco cigarettes. Also, I don't cough my head off when I wake up in the morning anymore. My breathing has improved considerably over the past 6 months I've been using my PV, (personal vaporizer). If my government, and the Medical Community, as well as the Insurance industry really gave a damn about the Peoples health. . .they would be passing these eCigarettes out free to anybody that smoked tobacco. But, the government needs the taxes; the Doctors need the work, the tobacco growers need to sell their poison; and I have no idea how the insurance industry justifies their position. Not even considering the health benefits. . .look at the "Manyears" of productivity that businesses could recoup. Sort of showes me where all these entities loyalties REALLY are. JMHO

Cheers,otrpu

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